Quality Assurance Specialist

Mallinckrodt - Madison, WI3.4

The Quality Assurance Specialist is responsible for supporting the quality system processes and for maintaining quality assurance standards, processes, and controls.

Essential Job Functions:
1. Oversee the generation, review, and archival of documents used to support Good Manufacturing Practice manufacture of Final Product.

2. Support internal and external audits as assigned.

3. Review and release raw materials, intermediate products and finished products.

4. Perform review of OOS, deviations, nonconformance, and investigation as required.

5. Ensure systems are in compliance with current SOPs.

6. Assist investigations and resolve potential product quality issues to improve efficiency.

7. Assist with writing, revising, and approving standard operating procedures.

8. Review and approve SOP, protocols and reports as necessary.

9. Submit, coordinate, route, and monitor document control activities.

9. Coordinate and/or conduct GMP training of peers and or personnel of other departments, as required.

10. May perform additional duties as required.

Essential Job Requirements:
1. Bachelors’ degree in a scientific discipline.

2. At least 2 years experience in cGMP environment within relevant Quality Assurance/Compliance functions.

3. Excellent writing and communication skills a must.

4. MS Excel and Power Point proficiencies a must.

5. Ability to work flexible hours occasionally to support production needs or inspections, is required.

6. Ability to travel is required.